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76 catalysts · 24 device recall · 20 device pma · 17 approval · 12 device 510k · 3 grant
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76 catalysts · 24 device recall · 20 device pma · 17 approval · 12 device 510k · 3 grant
Sponsor: JANSSEN PRODS. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION
Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS
Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION
Sponsor: HUMANWELL PURACAP. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL
Sponsor: ALMATICA. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL
Sponsor: CELGENE CORP. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: ASCENDIS. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS
Sponsor: CAPLIN. Form: INJECTABLE. Route: INJECTION
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: CIG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MVL. Advisory committee: Unknown. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: LFD. Advisory committee: Unknown. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: ETN. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QYI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LTJ. Advisory committee: IM. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
SIGNA Premier systems — Reason: Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury. — Status: Ongoing